A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants

A Randomized, Double-blind, Placebo-controlled and Parallel Group Adaptive Phase 2b/3 Trial to Evaluate the Efficacy and Safety of TNM001 Injection for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants Under One Year of Age

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), neutralizing antibody and antidrug antibody (ADA) response for TNM001 in infants entering their first RSV season.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: TNM001; Biological: placebo

Detailed Description

This study adopts an adaptive seamless dose selection design and consists of two parts: Part 1 is a phase 2b dose ranging trial which will support to determine the dose for Part 2, the phase 3 trial. The study population includes early and mid-term preterm infants [gestational age (GA)﹤35 weeks 0 day] and late preterm infants or full-term infants (≥35 weeks 0 day GA), with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD). A total of approximately 2250 infants will be randomized 2:1 to receive either TNM001 or placebo. All subjects will be followed for 240 days after dosing. This study will be conducted in appropriately 50 sites in China.

• Study Type: Interventional
• Enrollment (Actual): 2282
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100000
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100020
      • Children's Hospital Capital Institute Pediatrics
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400000
      • Jiangjin Central Hospital
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Xiamen Maternal and Child Health Hospital
  • Guangdong
    • Guangdong, Guangdong, China, 510150
      • The Third Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China, 511442
      • Guangdong Maternal and Child Health Care Hospital
    • Shenzhen, Guangdong, China, 518000
      • University of Chinese Academy of Sciense Shenzhen Hospital
  • Guangxi
    • Guilin, Guangxi, China, 541001
      • Affiliated Hospital of Guilin Medical University
    • Liuchow, Guangxi, China, 545006
      • Liuzhou People's Hospital
    • Nanning, Guangxi, China, 530002
      • Maternity and Child Health Care of Guangxi Zhuang Autonomous Region
  • Hainan
    • Haikou, Hainan, China, 570312
      • Hainan Women and Children's Medical Center
  • Hebei
    • Langfang, Hebei, China, 065000
      • Hebei Petro China Central Hospital
    • Shijiazhuang, Hebei, China, 050000
      • The Fourth Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of HeBei Medical University (HBMU)
    • Tangshan, Hebei, China, 063000
      • Tangshan Maternal and Child Health Hospitaltangshan Maternal and Child Health Hospital
  • Henan
    • Sanmenxia, Henan, China, 472000
      • Sanmenxia Central Hospital
    • Xinxiang, Henan, China, 453000
      • Xinxiang First People's Hospital
    • Zhengzhou, Henan, China, 450052
      • Henan (Zhengzhou) Children's Hospital
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430060
      • The Central Hospital of Wuhan
  • Hunan
    • Changde, Hunan, China, 415000
      • The First People's Hospital of Changde City
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
    • Changsha, Hunan, China, 410013
      • The Third XIANGYA Hospital of Central South University
    • Changsha, Hunan, China, 410008
      • The Maternal and Child Health Hospital of Hunan Province
    • Hengyang, Hunan, China, 421001
      • The Second Hospital University of South China
    • Loudi, Hunan, China, 417099
      • Loudi Central Hospital
    • Shaoyang, Hunan, China, 422000
      • The First Affiliated Hospital of Shaoyang University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Jiangxi Maternal and Child Health Hospital
  • Shandong
    • Jinan, Shandong, China, 250022
      • Children's Hospital Affiliated to Shandong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • The affiliated children'shospital fudan university
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Linfen People's Hospital
    • Linfen, Shanxi, China, 041000
      • Linfen Central Hospital
    • Yuncheng, Shanxi, China, 044000
      • Yuncheng Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Chengdu Women's and Children's Central Hospital
    • Chengdu, Sichuan, China, 610000
      • West China Second University Hospital, Sichuan University
    • Chongqing, Sichuan, China, 404100
      • Children's Hospital of Chongqing Medical University
    • Mianyang, Sichuan, China, 621000
      • Mianyang Peoples Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine/Hangzhou First People's Hospital
    • Ningbo, Zhejiang, China, 315012
      • Ningbo Women&Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Early and mid-term preterm infants (<35 weeks 0 day GA) and late preterm infants or full-term infants (≥35 weeks 0 day GA) under 1 year of age, with or without Congenital Heart Disease (CHD) or premature infants Chronic Lung Disease (CLD)，who are entering their first RSV season at the time of screening.

Exclusion Criteria:

• 1. Any fever (> 38.0°C) or acute illness within 7 days prior to randomization
• 2. History of RSV infection or active RSV infection prior to, or at the time of, randomization
• 3. Drug medication prior to randomization or expected to be treated by medicines during the study period.
• 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
• 5. Renal impairment or hepatic dysfunction
• 6. Nervous system disease or neuromuscular disease
• 7. Prior history of a suspected or actual acute life-threatening event
• 8. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
• 9. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
• 10.Receipt of RSV vaccine or mAb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: placebo; single dose intramuscular injection
Experimental: TNM001	Biological: TNM001; single dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of medically attended LRTI due to RT-PCR confirmed RSV	150 days post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of hospitalization due to RT-PCR confirmed RSV LRTI	150 days post dose
Occurrence of adverse events (AEs)	240 days post dose
Change in body temperature (celsius)	240 days post dose
Change in blood pressure (mmHg)	240 days post dose
Change in heart rate (beats per minute)	240 days post dose
Change in respiratory rate (breaths per min)	240 days post dose
Number of subjects with clinical significant abnormality in physical examinations	240 days post dose
Serum concentration of single dose TNM001 at pre-specified timepoints	240 days post dose
Serum level of neutralizing antibody to RSV	240 days post dose
Positive rate of anti-drug antibody (ADA) to TNM001 in serum	240 days post dose

Collaborators and Investigators

• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Hanmin Liu, MD, West China Second Hospital, Sichuan University; Principal Investigator: Enmei Liu, MD, Children's Hospital of Chongqing Medical University; Study Director: Ying Wang, Zhuhai Trinomab Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: TNM001-301; CTR20232792 (Other Identifier: ENTER FOR DRUG EVALUATION, NMPA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No